Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Verapamil hydrochloride tablets, USP are indicated for the treatment of the following: 1. Angina at rest including: - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) - In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS: Accessory bypass tract) - Prophylaxis of repetitive paroxysmal supraventricular tachycardia Verapamil hydrochloride is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i
Verapamil Hydrochloride Tablets, USP 120 mg tablets are round, standard concave, white film-coated, scored, debossed "HP" above and "27" below on one side and plain on the reverse side, supplied as: NDC: 70518-1464-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature] and protect from light. Dispense in a tight, light-resistant container using a child-resistant closure. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
VERAPAMIL HYDROCHLORIDE- VERAPAMIL HYDROCHLORIDE TABLET REMEDYREPACK INC. ---------- VERAPAMIL HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Verapamil hydrochloride (verapamil HCl) tablets, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film- coated tablets containing 40 mg, 80 mg or 120 mg of verapamil hydrochloride. The structural formula of verapamil HCl is: C H N O • HCl M.W. = 491.08 Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4- dimethoxy-α-(1-methylethyl) hydrochloride Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, light mineral oil, sodium lauryl sulfate, titanium dioxide and hypromellose. CLINICAL PHARMACOLOGY Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. MECHANISM OF ACTION ANGINA: The precise mechanism of action of verapamil hydrochloride as an antianginal agent remains to be fully determined, but includes the following two mechanisms: 1. _ Relaxation and prevention of coronary artery spasm:_ Verapamil hydrochloride dilates the main coronary arteries and coronary arterioles, both in normal and ischemic regions, and is a potent inhibitor of coronary artery spasm, whether spontaneous or 27 38 2 4 ergonovine-induced. This property increases myocardial oxygen delivery in patients with coronary artery spasm and is responsible for the effectiveness of verapamil hydrochloride in vasospastic (Prinzmetal's or var Прочетете целия документ